New Drugs to Treat Old Diseases
Compass On Business Feature

In this new feature, an executive presents a business challenge he or she faces and we ask other business leaders to share their experience grappling with a similar problem.

Danny Lewis operates the kind of business that did not exist when many Compass on Business readers were born. As president and CEO of Huntsville, Alabama-based Expression Genetics Inc., Lewis runs a biotechnology firm that seeks to develop breakthrough treatments for cancer and other diseases.

Founded in 2002, Expression Genetics develops therapeutic agents that target a specific part of the body for a specific time frame. This "timed release" form of drug delivery enables the firm's products—which rely on DNA and RNA as active agents—to deliver actual genes to cells or knock out "bad actor" genes within the body.

CoB: You've been on the forefront of drug advances for more than 35 years. How do you innovate?
DL: Truthfully, there's usually a lot of luck involved in inventions. One often makes a discovery totally aside from his original plan. Nevertheless, I conduct two types of analysis. First, I review the existing information in a particular field of study. I look for what's worked, what hasn't worked and what looks promising. I try to find fertile ground for innovation. Second, I reflect on my experience. I've learned how to innovate from my mistakes and my successes.

CoB: How do you extract the most value from information?
DL: The first trick is to pass over what's unimportant and to look for gems of what's truly outstanding and useful information. Because there's so much information in the biotech field today, you really only have time to scan abstracts and titles of articles in journals to find the most useful information nuggets.

CoB: What is the status of your company's therapeutic agents?
DL: Our lead product is in clinical development for the treatment of ovarian cancer. It differs from conventional chemotherapy by activating a patient's immune system to fight the cancer. We also have a full product pipeline at various phases of development. While we have three products on the market now that are reagents used in biotech research, we're really excited about the potential of our novel therapeutic agents to treat cancer patients.

CoB: When might these new treatments be ready?
DL: We hope to reach the market in four to five years. We're currently in the early clinical phase.

CoB: How do you motivate employees when the payoff is so far in the future?
DL: Our employees take pride in seeing our innovations reach the human testing phase. Now that our lead product is being tested in university medical clinics, our employees keep up with how it's performing on a daily basis. They constantly want to know if it increased survival for a patient or if it's doing what we hoped it would. We also provide stock options to all employees so that they can share in the company's future financial success.

CoB: Do you enjoy R&D?
DL: It's fulfilling to solve a real-life problem that can benefit society. I enjoy projects that aim to fill an unmet medical need, rather than do research for the sake of research. Many people think of R&D as just research, but the "D" side is equally important. Of course, one must have the research to have products or concepts to fully develop.

CoB: And you prefer the development side?
DL: Yes, it's more tangible. The development mind-set differs from the research mind-set. because timing is everything. Getting a drug to market and meeting deadlines and critical milestones is crucial. With discovery research, you have more latitude in terms of timing as well as directions for the projects to go.

CoB: Your firm recently won a federal Small Business Innovation Research (SBIR) grant to research your lead product for brain cancer. Are grants a big part of your funding?
DL: We don't rely heavily on grants. We rely more on equity financing and private investors. Still, we do occasionally apply for grants and we are grateful when we get funding through them.

CoB: What makes a successful grant application?
DL: In writing grants, I put myself in the reviewer's shoes. It helps that I've been a reviewer and I've served on grant review committees, so I can anticipate what they need when they look at our company's grant proposals. A good grant proposal has a concise, clear plan of work with specific goals. It states what innovation is to be expected as a result of the work. In the biotech sector, the competition for grants is fierce. Plus, it can take two to three years to get the funding. So that's why we use other funding mechanisms besides grants.

CoB: What inspires you?
DL: Seeing people, sometimes even my own family members, receive a medical benefit from one of our drug delivery inventions. Additionally, I read biographies of U.S. military leaders such as Grant, Lee, Patton and Eisenhower. They've faced the toughest life-or-death decisions.

Opinions expressed are those of the author(s) and do not necessarily represent the opinions of Compass Bank.

June 2008